(p. A17) As former FDA commissioners, we are confident in the FDA’s career scientists to oversee vaccine development rigorously.
If a Covid vaccine clears this process, it could be made available initially to specific groups of people through an Emergency Use Authorization. This emergency authority enables the FDA to make products available before a full application is approved by the agency. Congress created the emergency-use pathway as part of the Project BioShield Act of 2004, which provided for the development of medical countermeasures against chemical, biological, radiological and nuclear threats. Following 9/11 and anthrax, lawmakers expected an urgent need for such defenses.
After the 2009 swine flu, Congress expanded this pathway in the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, a bipartisan measure aimed at preparing the country to weather a pandemic. The law streamlined the application process for emergency use, expanded the classes of drugs eligible, and broadened the testing the FDA could require.
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This authority enables the staged entry of a vaccine. It’s unlikely that a Covid-19 vaccine will receive full approval and broad distribution right away. Instead, the FDA will probably authorize vaccines for use in targeted groups of people at high risk from Covid and most likely to benefit from the vaccine. For them, it may make sense to provide access to the vaccine before long-term follow-up studies that address very remote risks.
This might include health-care providers or first responders, who face greater exposure, or older people, who are more prone to severe complications if infected.
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This process exists precisely to deal with public-health emergencies like Covid-19. It isn’t a lower standard for FDA approval. It’s a more tailored, flexible standard that helps protect those who need it most while developing the evidence needed to make the public confident about getting a Covid-19 vaccine.
For the full commentary, see:
(Note: ellipses added.)
(Note: the online version of the commentary has the date Sep. 13, 2020, and has the same title as the print version.)